MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Jun 6, 2019
Report 1219029-2019-00012 · MDR key 8676538
Device
Generic name
Glucose Test System
Manufacturer
Nova Biomedical Corp.Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NOVA BIOMEDICAL AWAITING ADDITIONAL INFORMATION REGARDING THE REPORTED INCIDENT(S). BARCODES HAVE BEEN RETURNED BY THE CUSTOMER FOR EVALUATION BUT NOVA IS STILL WAITING FOR THE AFFECTED METERS TO BE RETURNED. INVESTIGATION ONGOING.
Description of Event or Problem
NOVA STATSTRIP HOSPITAL METERS INTERMITTENTLY SCAN PATIENT IDS FROM 1-D BARCODES INCORRECTLY.